Clinical Research Regulatory Coordinator - Oncology Therapeutics

Penn State University; United States; On-site; USD 65,000 - 90,000; Full time

Job summary

The Penn State College of Medicine in Hershey, PA seeks a Clinical Research Regulatory Coordinator to oversee regulatory management for oncology trials conducted by the Experimental Therapeutics (Extract) Team. You will work with investigators, sponsors, CROs, and regulatory offices to ensure compliance with FDA, ICH-GCP, and institutional policies, across start-up, activation, maintenance, and closeout.

Ideal candidates have oncology regulatory affairs experience, strong organization, and the

Qualifications

• Bachelor's Degree
• 3+ years of relevant experience; oncology regulatory experience preferred

Responsibilities

• Coordinate regulatory start-up and activation activities for oncology trials
• Prepare and submit IRB applications, continuing reviews, amendments, and consent revisions
• Maintain regulatory files and Investigator Site Files (ISFs)
• Monitor regulatory approvals and training/compliance deadlines
• Serve as primary regulatory contact for assigned trials

Skills

Regulatory affairs

Oncology experience

IRB submissions

Education

Bachelor's Degree

Tools

Regulatory databases

IRB submission tools

Job description

POSITION SPECIFICS

The Penn State College of Medicine, in Hershey, Pa is seeking a Clinical Research Regulatory Coordinator. This position is responsible for the regulatory management of Oncology clinical trials conducted by the Experimental Therapeutics (Extract) Team at Penn State College of Medicine. This position independently manages regulatory activities across an assigned portfolio of oncology clinical trials, supporting study start-up, activation, ongoing maintenance, and closeout.

Working closely with Principal Investigators, clinical research staff, sponsors, contract research organizations (CROs), and institutional regulatory offices, the coordinator ensures regulatory compliance with institutional policies, FDA regulations, and Good Clinical Practice (GCP) guidelines.

The ideal candidate will have experience in clinical research regulatory affairs, preferably within oncology therapeutics, strong organizational skills, and the ability to independently manage multiple studies and competing deadlines.

Approval of remote and hybrid work is not guaranteed regardless of work location. For additional information on remote work at Penn State, see Notice to Out of State Applicants.

This position is funded for 1 year(s); continuation past 1 year(s) will be based on university need, performance, and/or availability of funding.

Essential Duties and Responsibilities

1. Regulatory Study Start-Up and Maintenance
   • Coordinate regulatory start-up and activation activities for industry-sponsored, investigator-initiated, cooperative group, and federally sponsored oncology trials.
   • Prepare and submit initial IRB applications, continuing reviews, protocol amendments, informed consent revisions, personnel changes, and other required regulatory submissions.
   • Collect, review, and maintain essential regulatory documents, including protocols, investigator brochures, CVs, licenses, training records, and financial disclosures.
   • Independently manage regulatory requirements and submission timelines for an assigned portfolio of clinical trials.
   • Maintain accurate, complete, and current regulatory files and Investigator Site Files (ISFs).
   • Monitor regulatory approvals, expiration dates, training requirements, and compliance deadlines.
2. Oncology-Specific Regulatory Compliance
   • Provide regulatory support for Phase I, II, and III oncology therapeutic clinical trials involving investigational agents and novel cancer treatments.
   • Coordinate regulatory documentation and requirements associated with IND studies, investigational products, safety updates, and protocol amendments.
   • Ensure compliance with applicable FDA regulations, ICH-GCP guidelines, and institutional research policies.
   • Identify and address regulatory deficiencies and ensure study documentation remains current and compliant.
3. Quality Assurance and Study Closeout
   • Maintain regulatory files in an audit- and inspection-ready state.
   • Coordinate preparation for sponsor monitoring visits, internal audits, and regulatory inspections.
   • Perform quality checks to ensure regulatory documentation is accurate, complete, and compliant.
   • Coordinate final regulatory submissions, IRB study closure, and long-term document archiving.
4. Communication and Collaboration
   • Serve as a primary regulatory contact for assigned oncology clinical trials.
   • Collaborate with investigators, clinical research coordinators, research nurses, sponsors, CROs, and institutional regulatory personnel.
   • Communicate regulatory requirements, timelines, and outstanding documentation needs to research team members.
   • Contribute to regulatory process improvements and support research staff with study-specific regulatory requirements.

Preferred Qualifications

• Previous experience in oncology clinical research, preferably supporting oncology therapeutic clinical trials.
• Experience with Phase I, II, and/or III oncology clinical trials.
• Experience with regulatory submissions for industry-sponsored, investigator-initiated, and cooperative group oncology studies.
• Familiarity with FDA regulations, IND studies, and ICH-GCP guidelines.
• Experience with IRB submissions and electronic regulatory document management systems.

MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS

If filled as Clinical Research Coordinator - Advanced Professional, this position requires:

• Bachelor's Degree
• 3+ years of relevant experience; or an equival